POLARSTEM 75103197Recalls & reported problems
Smith & Nephew, Inc. · POLARSTEM DAA OFFSET ADAPTER 45 · Class 1
All models of POLARSTEM (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556724385), received between Mar 12, 2021 and Mar 12, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE DISTANCE OF THE INSTRUMENT BETWEEN RASP ADAPTER AND SPRING SHOULD BE 3 CM LONGER, SINCE THE SPRING RELEASES UNINTENTIONALLY WITH EACH HAMMER BLOW AND THE RASP THEREFORE COMES OFF THE ADAPTER OR IS RELEASED TOO EARLY AND HAS TO BE PUT BACK ON. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. A DELAY OF 10 MINUTES OR LESS WAS REPORTED. THE PROBLEM OCCURS WHILST USING THE DAA (DIRECT ANTERIOR APPROACH) SURGICAL METHOD (ACCESS TO THE HIP JOINT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11468401 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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